Easy start cannulated bone screw

ABSTRACT

A surgical screw for fixation into bone or soft tissue. The surgical screw includes a cannulated body having a proximal end and a distal end. The distal end of the cannulated body has a tapered tip and a plurality of threads extend around the exterior of the cannulated body. An introducer extends distally from the tapered tip and has a diameter (which can be variable or constant) which is less than a diameter of the tapered tip. The surgical screw is cannulated such that a channel extends through the body from the proximal end to (and sometimes through) the distal end.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application Serial No.16/764,634 filed on May 15, 2020 (now U.S. Pat. No. 11,490,938) which isa National Stage Application under 35 U.S.C. 371 based on InternationalPatent Application PCT/US18/53412 filed on Sep. 28, 2018 which claimspriority to U.S. Provisional Pat. Application Serial No. 62/569,770,filed on Oct. 9, 2017 and entitled “Easy Start Cannulated Bone Screw,”and U.S. Provisional Pat. Application Serial No. 62/599,228, filed onDec. 15, 2017 and entitled “Easy Start Cannulated Bone Screw,” theentireties of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present disclosure is directed generally to a surgical fixationdevice and, more particularly, to a cannulated screw for fixation intobone or soft tissue.

2. Description of Related Art

In orthopedic surgeries, screws are often used to secure and fixbiological material or another object, such as an implant, in a desiredposition relative to a bone. For example, screws are used to attach abone block to an existing bone or to secure soft tissue to a bone orsoft tissue. The initial threading of the screw into the bone or a boneblock can be difficult. Therefore, in some procedures, a pilot hole isrequired to aid in alignment of the screw. As well understood in thesurgical field, the pilot hole is smaller in depth and diameter than thescrew to provide a guide for the screw, while still being narrow enoughto allow enough of the threads of the screw to penetrate the boneyinterference site. A mallet may also be used to hammer the screw deepenough for the threads to penetrate the boney interference site.

Drilling a pilot hole requires additional surgical time and additionalsurgical instruments. While using a mallet to hammer the screw into thebone may be less time consuming and require less instrumentation, it isless precise. Hammering the screw into the bone carries a greater riskthat the screw will become misaligned with the desired fixationlocation. Therefore, there is a need for a surgical screw that does notrequire the use of a pilot hole or a mallet, while maintaining sturdyand reliable fixation within the bone.

SUMMARY OF THE INVENTION

The present invention is directed to a surgical screw. The surgicalscrew comprises features for reducing the torque required to start orintroduce the screw into the anatomy. According to one aspect, thesurgical screw includes a cannulated body having a proximal end and adistal end. The distal end of the cannulated body can have a taperedtip, and a plurality of threads which can extend around the exterior ofthe cannulated body from a position at the very distal end, a positionadjacent to the distal end, or a position proximal to the distal end toa position at the very proximal end, a position adjacent to the distalend, or a position distal of the proximal end. An introducer extendsdistally from the tapered tip and has a diameter (which can be constantor variable) which is less than a diameter of the tapered tip. Thesurgical screw is cannulated such that a channel extends through thebody from the proximal end to the distal end.

According to another aspect, the surgical screw includes a cannulatedbody having a proximal end and a distal end, which has a tapered tip. Aplurality of threads extend around the exterior of the cannulated body(from positions as described above). The plurality of threads include aprimary thread and a secondary thread. A lead of the primary thread isgreater than a pitch of the plurality of threads. An introducer extendsdistally from the tapered tip. The surgical screw is cannulated suchthat a channel extends through the body from the proximal end to thedistal end.

It should be appreciated that all combinations of the foregoing conceptsand additional concepts discussed in greater detail below (provided suchconcepts are not mutually inconsistent) are contemplated as being partof the inventive subject matter disclosed herein. In particular, allcombinations of claimed subject matter appearing at the end of thisdisclosure are contemplated as being part of the inventive subjectmatter disclosed herein. It should also be appreciated that terminologyexplicitly employed herein that also may appear in any disclosureincorporated by reference should be accorded a meaning most consistentwith the particular concepts disclosed herein.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiment(s) described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more aspects of the present invention are particularly pointedout and distinctly claimed as examples in the claims at the conclusionof the specification. The foregoing and other objects, features, andadvantages of the invention are apparent from the following descriptiontaken in conjunction with the accompanying drawings in which:

FIG. 1 is a proximal perspective view schematic representation of asurgical screw, according to an embodiment;

FIG. 2 is a distal perspective view schematic representation of asurgical screw, according to an embodiment;

FIG. 3 is side view schematic representation of a surgical screw,according to an embodiment;

FIG. 4 is a perspective view schematic representation of a surgicalscrew, according to an alternative embodiment;

FIG. 5 is a side view schematic representation of a surgical screw,according to an alternative embodiment;

FIG. 6 is a distal perspective view schematic representation of asurgical screw, according to an alternative embodiment;

FIG. 7 is a distal end view schematic representation of a surgicalscrew, according to an alternative embodiment;

FIG. 8 is a distal perspective view schematic representation of asurgical screw, according to an embodiment;

FIG. 9 is a side view schematic representation of a surgical screw,according to an alternative embodiment; and

FIG. 10 is a side view schematic representation of a surgical screw,according to another embodiment;

FIG. 11 is a side view schematic representation of a surgical screw,according to yet another embodiment;

FIG. 12 is a close-up view schematic representation of an exemplaryembodiment of a surgical screw with a single start; and

FIG. 13 is a close-up view schematic representation of an exemplaryembodiment of a surgical screw with a double start.

DETAILED DESCRIPTION OF THE INVENTION

Aspects of the present invention and certain features, advantages, anddetails thereof, are explained more fully below with reference to thenon-limiting examples illustrated in the accompanying drawings.Descriptions of well-known structures are omitted so as not tounnecessarily obscure the invention in detail. It should be understood,however, that the detailed description and the specific non-limitingexamples, while indicating aspects of the invention, are given by way ofillustration only, and are not by way of limitation. Varioussubstitutions, modifications, additions, and/or arrangements, within thespirit and/or scope of the underlying inventive concepts will beapparent to those skilled in the art from this disclosure.

Referring now to the figures, wherein like reference numerals refer tolike parts throughout, FIG. 1 shows a proximal perspective viewschematic representation of a surgical screw 100, according to anembodiment. The surgical screw 100 comprises a body 102 extendingbetween a proximal end 104 and a distal end 106. The surgical screw 100can be composed of any suitable biocompatible material, such as titaniumor magnesium, and can be manufactured according to common manufacturingmethods, such as machining (as should be understood by a person ofordinary skill in the art in conjunction with a review of thisdisclosure). The surgical screw 100 may also be composed ofbio-composite material and manufactured via injection molding (as shouldbe understood by a person of ordinary skill in the art in conjunctionwith a review of this disclosure).

As shown in FIG. 1 , the body 102 comprises a feature 108 at theproximal end 104 that allows the surgical screw 100 to be torqued.Specifically, the feature 108 is on an outer surface 110 of the proximalend 104. For example, the feature 108 can be that of any conventionalscrew head and non-conventional geometries as well (e.g., Tri-Lobedriver geometry). In the depicted embodiment, the feature 108 has ahexagonal cross-section. As shown in FIG. 1 , the surgical screw 100 iscannulated such that a channel 112 extends from the feature 108 at theouter surface 110 of the proximal end 104 through the body 102 to thedistal end 106.

Turning now to FIG. 2 , there is shown a distal perspective viewschematic representation of the surgical screw 100, according to anembodiment. In the depicted embodiment, the body 102 of the surgicalscrew 100 comprises a tip 114 at the distal end 106. In FIG. 2 , the tip114 is a tapered region (at least partially tapered, can be tapered allthe way to the very distal end, and can include a constant, variable -increasing or decreasing taper, or more than one taper (which may beseparated with a section with no taper) with the same or different tapervalue) such that the body 102 is tapered toward the distal end 106. Asdescribed above, the surgical screw 100 is cannulated. FIG. 2 shows thechannel 112 extending through the body 102 of the surgical screw 100 tothe tip 114 at the distal end 106. Specifically, the channel 112 extendsfrom the feature 108 at the proximal end 104 to an opening 116 on anouter surface 118 of the tip 114.

Still referring to FIG. 2 , the surgical screw 100 comprises anintroducer 120 at the tip 114. In the depicted embodiment, theintroducer 120 is an elongated extension from the tip 114. In thedepicted embodiment, the introducer 120 is a narrow cylinder extendingfrom the tip 114 at the distal end 106. As shown, the introducer 120 isalso cannulated such that the introducer 120 has the outer surface 118with the opening 116 to the channel 112 extending through the body 102.The introducer 120 allows for easier insertion of the surgical screw 100because the introducer 120 can be used to align the surgical screw 100at the desired bone hole location.

Referring now to FIG. 3 , there is shown a side view schematicrepresentation of the surgical screw 100, according to an embodiment. Asshown in FIG. 3 , the surgical screw 100 comprises a plurality ofthreads 122 along the length of the body 102. As with all conventionalscrews, adjacent threads 122 have a pitch p and root diameter d.However, the pitch p and therefore, the root diameter d of the depictedembodiment of the surgical screw 100 can be variable/non-constant(alternatively, the pitch can be variable and the root diameter can beconstant or vice versa, and the pitch and/or the root diameter can bevariable for a certain length of the body and constant for anotherlength of the body). In other words, the threads 122 of the surgicalscrew 100 are not evenly spaced. In one embodiment, the pitch pincreases from the proximal end 104 to the distal end 106, while theroot diameter d increases from the distal end 106 to the proximal end104. For example, as shown in FIG. 3 , the pitch p 1 at the distal end106 is larger than the pitch p 2 at the proximal end 104, and the rootdiameter at the distal end 106 is smaller than the root diameter at theproximal end 104.

Still referring to FIG. 3 , the threads 122 of the surgical screw 100are dual start threads. Dual start threads are two threads opposed at180 degrees. As shown in FIG. 3 , the surgical screw 100 comprises astaggered start 124. In other words, a secondary thread 128 begins 180degrees later than a primary thread 126. As shown in FIG. 13 , theprimary thread 122A has a lead L, which is greater than the pitch p ofthe threads 122 (122A, 122B) when the surgical screw 100 has a dualstart or staggered start 124. The surgical screw 100 may also have atriple start or any additional multiple start (as should be understoodby a person of ordinary skill in the art in conjunction with a review ofthis disclosure, not shown) or a single start (FIG. 12 ) where the leadL and the pitch p are equal. In an embodiment, as shown in FIG. 3 , theprimary thread 126 has a reduced surface area A. The reduced surfacearea A reduces resistance and lowers torque during initial engagementwith the bone.

Turning now to FIGS. 4-11 , there are shown various views schematicrepresentations of surgical screw 100 according to alternativeembodiments. First, in FIG. 4 , there is shown a perspective viewschematic representation of a surgical screw 100, according to analternative embodiment. As with the surgical screw 100 in FIGS. 1-3 ,the surgical screw 100 in FIG. 4 comprises a body 102 extending betweena proximal end 104 and a distal end 106 with a feature 108 on an outersurface 110 at the proximal end 104, which allows the surgical screw 100to be torqued. As shown in FIG. 4 , the surgical screw 100 is cannulatedsuch that a channel 112 extends from the feature 108 at the outersurface 110 of the proximal end 104 through the body 102 to the distalend 106. As with the surgical screw 100 of FIGS. 1-3 , the surgicalscrew 100 shown in FIGS. 4-11 can be composed of any suitablebiocompatible material, such as titanium or magnesium, or bio-compositematerial, and can be manufactured according to common manufacturingmethods, such as machining or injection molding, for example.

FIG. 5 shows a side view schematic representation of a surgical screw100, according to an alternative embodiment. The surgical screw 100shown in FIG. 5 has threads 122 extending along the body 102 of thescrew 100. Adjacent threads 122 in the depicted embodiment have aconstant (i.e., equal) pitch p. However, the surgical screw 100 may alsohave threads 122 with a variable pitch p 1, p 2, as shown in theembodiment in FIG. 3 . The embodiment of the surgical screw 100 in FIG.5 also has threads 122 with a root diameter d that is tapered from theproximal end 104 to the distal end 106. Specifically, the root diameterd decreases from the proximal end 104 to the distal end 106 (which canbe a constant decrease in diameter in some embodiments, and anon-constant decrease in diameter in other embodiments).

Still referring to FIG. 5 , the embodiment of the surgical screw 100also includes a dual start thread (i.e., staggered start) 124. As statedabove, the dual start thread 124 includes a primary thread 126, which is180 degrees opposed from a secondary thread 128 such that the secondarythread 128 starts 180 degrees later (i.e., around the exterior of thebody 102) than the primary thread 126. However, in other embodiments,the secondary thread 128 can start anywhere from a little as 5 degreesto as most as 360 degrees later than the primary thread 126. The primarythread 126 and secondary thread 128 have reduced surface areas A1, A2 toreduce resistance and lower torque during initial engagement with thebone.

Turning now to FIGS. 6-7 , there are shown distal end and distalperspective views schematic representations of a surgical screw 100,according to an alternative embodiment. In the depicted embodiment ofthe surgical screw 100, the primary thread 126 and the secondary thread128 are chamfered. The chamfering removes a leading edge from theprimary and secondary threads, further reducing the surface area A1, A2thereof. As shown in FIG. 6 , the chamfering creates a first sharp edge130 on the primary thread 126 and a second sharp edge 132 on thesecondary thread 128. The sharp edges 130, 132 allow for betterengagement between the surgical screw 100 and bone. In the depictedembodiment, the distal portion 134 of the primary thread 126 isconfigured such that the surface area A1 of the primary thread 126 isfurther reduced as compared to the surface area A2 of the secondarythread 128. In additional embodiments, a radius is used in place of thechamfer when the surgical screw 100 is used for engagement with softtissue as opposed to bone.

Referring now to FIG. 8 , there is shown a distal perspective viewschematic representation of a surgical screw 100, according to anembodiment. In the depicted embodiment, the surgical screw 100 includesa notching feature 136 at the distal end 106. In one embodiment, asshown in FIG. 8 , the notching feature 136 extends from the introducer120 at the distal end 106 of the surgical screw 100. In the depictedembodiment, the notching feature 136 is a notch that extendsapproximately tangentially from the introducer 120. The notching feature136 can be malleted into the bone when the bone is hard. For example, asurgeon will align the introducer 120 at the desired bone hole locationand mallet the proximal end 104 of the surgical screw 100 such that theintroducer 120 and notching feature 136 engage the bone. In anotherembodiment, the notching feature 136 is used to find gaps between aprimary bone and a graft when the surgical screw 100 is rotated. Whenthe notching feature 136 finds a gap, it directs the primary thread 126to the desired area and the surgical screw 100 can be rotated andinstalled without the need for malleting.

Turning now to FIGS. 9-10 , there are shown side views schematicrepresentations of a surgical screw 100, according to additionalembodiments. In the embodiment shown in FIGS. 9-10 , the opening 116 tothe channel 112 at the distal end 106 (introducer 120) of the surgicalscrew 100 is solid or otherwise replaced with a solid feature 138. Thesolid feature 138 may be rounded, as shown in FIG. 9 , or the solidfeature 138 may have any other suitable geometry. For example, the solidfeature 138 may be a drill tip 140, as shown in FIG. 10 . In theembodiments shown in FIGS. 9-10 , the solid feature 138 is notcannulated. However, in alternative embodiments, the cannulation mayalso be completely removed (as in FIGS. 9-10 ) or only partiallyremoved. In other words, the solid feature 138 can be either completelysolid or only partially solid.

Referring now to FIG. 11 , there is shown a side view schematicrepresentation of a surgical screw 100, according to yet anotherembodiment. In the depicted embodiment, the surgical screw 100 comprisesone or more exterior markings 142 along the body 102 between theproximal end 104 and the distal end 106. The exterior markings 142 ofthe surgical screw 100 in FIG. 11 are depth indicator markings 142. Thedepth indicator markings 142 are visible to a surgeon (or other user)during rotation and installation of the surgical screw 100. The depthindicator markings 142 allow the surgeon to determine the depth of thesurgical screw 100 within the bone or soft tissue. In the depictedembodiment, the depth indicator markings 142 are circumferentialmarkings extending around the exterior of the surgical screw 100.However, the depth indicator markings 142 can be placed anywhere alongthe exterior of the surgical screw 100 such that they are visible to thesurgeon (or other user). As shown in FIG. 11 , the depth indicatormarkings 142 can include multiple markings 142 spaced at equidistantintervals (e.g., 5 mm), a single depth marking, or multiple markingsspaced at irregular intervals, as desired, and can be made from orcoated with radiographic material.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

While various embodiments have been described and illustrated herein,those of ordinary skill in the art will readily envision a variety ofother means and/or structures for performing the function and/orobtaining the results and/or one or more of the advantages describedherein, and each of such variations and/or modifications is deemed to bewithin the scope of the embodiments described herein. More generally,those skilled in the art will readily appreciate that all parameters,dimensions, materials, and configurations described herein are meant tobe exemplary and that the actual parameters, dimensions, materials,and/or configurations will depend upon the specific application orapplications for which the teachings is/are used. Those skilled in theart will recognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments describedherein. It is, therefore, to be understood that the foregoingembodiments are presented by way of example only and that, within thescope of the appended claims and equivalents thereto, embodiments may bepracticed otherwise than as specifically described and claimed.Embodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the scope of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as, “has” and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (any formof contain, such as “contains” and “containing”) are open-ended linkingverbs. As a result, a method or device that “comprises”, “has”,“includes” or “contains” one or more steps or elements. Likewise, a stepof method or an element of a device that “comprises”, “has”, “includes”or “contains” one or more features possesses those one or more features,but is not limited to possessing only those one or more features.Furthermore, a device or structure that is configured in a certain wayis configured in at least that way, but may also be configured in waysthat are not listed.

The corresponding structures, materials, acts and equivalents of allmeans or step plus function elements in the claims below, if any, areintended to include any structure, material or act for performing thefunction in combination with other claimed elements as specificallyclaimed. The description of the present invention has been presented forpurposes of illustration and description, but is not intended to beexhaustive or limited to the invention in the form disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the invention.The embodiment was chosen and described in order to best explain theprinciples of one or more aspects of the invention and the practicalapplication, and to enable others of ordinary skill in the art tounderstand one or more aspects of the present invention for variousembodiments with various modifications as are suited to the particularuse contemplated.

1. A surgical screw, comprising: a cannulated body having a proximal endand a distal end, the distal end having a tapered tip; a plurality ofthreads positioned around at least a portion of the exterior of thecannulated body; an introducer extending distally from the tapered tip;wherein the introducer has a diameter which is less than a diameter ofthe tapered tip; and a channel extending through the body from theproximal end to the distal end; wherein the plurality of threadsincludes a primary external thread and a secondary external thread bothpositioned around at least the tapered tip region, and wherein theprimary external thread extends around the whole of the tapered tipregion to the distal end of the tapered tip region.
 2. The surgicalscrew of claim 1, wherein the introducer is a cannulated cylinder suchthat the channel extends from the proximal end through the introducer.3. The surgical screw of claim 1, wherein the introducer comprises asolid feature.
 4. The surgical screw of claim 3, wherein solid featureis a drill tip.
 5. The surgical screw of any one of the precedingclaims, further comprising one or more exterior markings on thecannulated body indicating a depth.
 6. A surgical screw, comprising: acannulated body having a proximal end and a distal end, the distal endhaving a tapered tip; a plurality of threads positioned around at leasta portion of the exterior of the cannulated body; an introducerextending distally from the tapered tip; wherein the introducer has adiameter which is less than a diameter of the tapered tip; and a channelextending through the body from the proximal end to the distal end,wherein the plurality of threads includes a primary external thread anda secondary external thread both positioned around at least the taperedtip region, wherein at least the primary external thread extends aroundthe whole of the tapered tip region to the distal end of the tapered tipregion, and wherein the primary external thread has a first edge with areduced surface area at its distal end.
 7. The surgical screw of claim6, wherein the secondary thread has second edge with a reduced surfacearea at the tapered tip.
 8. A surgical screw, comprising: a cannulatedbody having a proximal end and a distal end, the distal end having atapered tip; a plurality of threads positioned around at least a portionof the exterior of the cannulated body; an introducer extending distallyfrom the tapered tip; wherein the introducer has a diameter which isless than a diameter of the tapered tip; and a channel extending throughthe body from the proximal end to the distal end, wherein the pluralityof threads includes a primary external thread and a secondary externalthread both positioned around at least the tapered tip, wherein theprimary external thread extends around the whole of the tapered tipregion to the distal end of the tapered tip region, and wherein theprimary thread has a first edge with a first surface area at the taperedtip and the secondary thread has a second edge with a second surfacearea at the tapered tip, wherein the first surface area is less than thesecond surface area.
 9. The surgical screw of any one of claims 6 to 8,wherein the first edge of the primary external thread is chamfered. 10.The surgical screw of claim 9, wherein the second edge of the secondaryexternal thread is chamfered.
 11. The surgical screw of any one ofclaims 8 to 10, wherein the first edge and the second edge are staggeredon the tapered tip.
 12. The surgical screw of any one of the precedingclaims, further comprising a notching feature extending from theintroducer.
 13. The surgical screw of claim 12, wherein the notchingfeature is a notch that extends approximately tangentially from theintroducer.
 14. The surgical screw of any one of the preceding claims,wherein the cannulated body is composed of titanium.
 15. The surgicalscrew of any one of the preceding claims, wherein a lead of the primarythread is greater than a pitch of the plurality of threads.
 16. Thesurgical screw of any one of the preceding claims, wherein each pair ofadjacent threads of the plurality of threads has a pitch and a rootdiameter, and each pitch is equal and each root diameter is equal. 17.The surgical screw of any one of the preceding claims, wherein theplurality of threads includes a first pair of adjacent threads and asecond pair of adjacent threads, the first pair of adjacent threadshaving a first pitch and the second pair of adjacent threads having asecond pitch, wherein the first pitch is greater than the second pitch.18. The surgical screw of any one of the preceding claims, wherein thefirst pair of adjacent threads have a first root diameter and the secondpair of adjacent threads having a second root diameter, wherein thefirst root diameter is greater than the second root diameter.
 19. Thesurgical screw of any one of the preceding claims, wherein the primarythread and the secondary thread are opposed at an angle within the rangeof 5 degrees to 360 degrees.
 20. The surgical screw of claim 19, whereinthe primary thread and the secondary thread are opposed at about 180degrees.
 21. The surgical screw of any one of the preceding claims,wherein the introducer is a cannulated cylinder.